Reporting by The Wall Street Journal and follow‑up by STAT and Fierce documents internal complaints against Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER), and details his decision to return a refusal‑to‑file (RTF) for Moderna’s influenza vaccine mRNA‑1010. Sources cited by WSJ allege interpersonal impropriety and staff pushback; internal memos reportedly argued against the blanket RTF. Moderna publicly disputed the agency’s move and criticized the decision given prior discussions with CBER. Moderna CEO Stéphane Bancel said the company expects comprehensive reviews of submissions using FDA‑approved comparators; company and agency disagreement centers on trial design and control arms. A refusal‑to‑file is an administrative determination that an application is not sufficiently complete to begin a substantive review, delaying regulatory timelines and triggering procedural disputes.